Puritan Bennett 980 Series Ventilator, 980A1ENNISB
Check against the official notice below — it lists the full affected range.
Covidien LLC is recalling the Puritan Bennett 980 Series Ventilator (model 980A1ENNISB) due to a manufacturing assembly error involving a capacitor that was installed incorrectly. This defect may cause the ventilator to stop working during use. A total of 278 units were distributed worldwide, including throughout the United States. The affected devices can be identified by serial numbers 35B1700507, 35B1700533, 35B1700539, 35B1700465, 35B1700580, 35B1700530, 35B17005363, 5B1700542, 35B1700509, 35B1701614, 35B1700527, 35B1700537, 35B1700541, 35B1700508, and 35B1701569, along with the UDI/GTIN 10884521201897.
The recall notice does not specify a remedy or instructions for affected consumers regarding what action they should take.
Written by software from the official notice below. Not reviewed by a lawyer.
Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use.
Reason for recall: Manufacturing assembly error where a capacitor within the ventilator was assembled incorrectly, which may cause the device to become inoperable during use. Distribution: Worldwide distribution - US Nationwide. Quantity: 278 total Lot/code info: GTIN/UDI - 10884521201897 Serial Numbers: 35B1700507, 35B1700533, 35B1700539, 35B1700465, 35B1700580, 35B1700530, 35B17005363, 5B1700542, 35B1700509, 35B1701614, 35B1700527, 35B1700537, 35B1700541, 35B1700508 & 35B1701569.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.